IntelligentMDx has secured clearance from the US Food and Drug Administration (FDA) for IMDx VanR for Abbott m2000 assay, an automated molecular diagnostic test that detects the presence of vanA and vanB genes associated with ...
EnteroMedics has submitted premarket approval (PMA) application to the US Food and Drug Administration (FDA) for Maestro Rechargeable System's VBLOC, a vagal blocking therapy to treat obesity. Maestro RC system delivers vagal blocking ...
Tags: EnteroMedics, Vbloc Therapy
British drug-maker GlaxoSmithKline (GSK) has reached settlement with the attorneys general of eight US states over misleading marketing of the diabetes treatment drug, Avandia, and even agreed to pay $229m to settle the lawsuits. Without ...
Tags: Avandia Lawsuits, Medicine
Hologic's Aptima HPV assay has received clearance from the US Food and Drug Administration (FDA) for use on its fully-automated Panther system, enabling laboratories to run multiple tests from a single specimen. A nucleic acid amplified ...
Tags: Panther System, Aptima HPV Assay
Abbott has obtained approval from US Food and Drug Administration (FDA) for its inpatient blood glucose monitoring system, called FreeStyle Precision Pro Blood Glucose and Beta-Ketone Monitoring System, which provides test results in real ...
Tags: Abbott, Monitoring System
Cepheid, a California-based medical device firm, has received market authorization from the US Food & Drug Administration (FDA) for its Xpert MTB/RIF test, a tuberclosis test. The regulatory agency approved following a de novo 510(k) ...
Tags: Cephid, Tuberclosis Test
Menasha Packaging, a subsidiary of Menasha Corporation, has unveiled new International Organization for Standardization (ISO) certified medical device unit in Edison, New Jersey. The new facility includes a lab and separate environment ...
Tags: Menasha Packaging, Medical Device
The US Food and Drug Administration (FDA) has dispatched warning letters to 15 firms, including foreign and domestic to desist from selling their illegally marketed diabetes products. The latest move will help the regulator to curb the ...
Tags: Diabetes'Medicines, active pharma
UK-based Randox Food Diagnostics is set to unveil a generic Tetracyclines ELISA screening kit based on Biochip Array Technology for veterinary residue testing. The company will launch the ELISA kit by the end of this month to complement ...
Tags: Randox Food, Screening Kit
Mylan Pharmaceuticals and Orion have entered into a settlement and license agreement, which dismisses the parties pending litigation related to Mylan's filing of an Abbreviated New Drug Application (ANDA) with the US FDA for the generic ...
Tags: Mylan, Orion, Generic Version
American Regent, a subsidiary of a Daiichi Sankyo Group Company named Luitpold Pharmaceuticals, has won USFDA approval for Injectafer (ferric carboxymaltose injection) for the treatment of iron deficiency anemia (IDA). A parenteral iron ...
Tags: Iron Deficiency Anemia, Medicine
Techne has completed the acquisition of Bionostics Holdings and its operating subsidiary Bionostics for approximately $104m in cash. Bionostics is a developer and manufacturer of control solutions that verify the correct operation of ...
Tags: Techne, Bionostics Acquisition
Hologic, a developer of medical imaging systems and surgical products, has received approval for its Aptima HPV assay for use on its fully-automated Panther system from the US Food and Drug Administration (FDA). The assay is a nucleic ...
Tags: Aptima HPV, Medicine
AbbVie's Humira (adalimumab), a rheumatoid arthritis drug, has been rejected by the US FDA advisors for use in the treatment of a spinal inflammatory disease, non-radiographic axial spondyloarthritis. The FDA's Arthritis Advisory ...
IMRIS has secured US Food and Drug Administration (FDA) 510K approval to market its VISIUS iCT, a ceiling-mounted intraoperative computed tomography (iCT). VISIUS iCT serves a surgical theater, providing personalized dose management along ...
Tags: Visius ICT, Medicine